ACL - Anterior Cruciate Ligament RuptureNEURO-K-STARTSNCT07659613
Assessment of NEURO-K-STARTS Following Primary Anterior Cruciate Ligament (ACL) Reconstruction
A study testing NEURO-K-STARTS in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Anterior cruciate ligament (ACL) reconstruction is the major treatment option for ACL injuries. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after return to sport (RTS). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- NEURO-K-STARTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient who has undergone primary ACL reconstruction at least 6 months ago
- Patient who has undergone an isokinetic strength test, the results of which do not indicate any contraindications to performing a functional test
- Patient who has resumed performing horizontal jumps under the supervision of a healthcare professional
- Patient with no history of surgery on the joints of the contralateral leg
- Patient enrolled in or covered by a social security scheme
- French-speaking patient who has signed an informed consent form
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- Subject with no history of surgery on the joints of either leg
- Subject who is member of or beneficiary of a social security scheme
- French-speaking subject who has signed an informed consent form
Who cannot join
- Patient with a history of ligament surgery on the affected or contralateral knee
- Patient with a BMI < 18.5 or > 30
- Patient who is professional athlete
- Patient with severe associated conditions (neurological, connective tissue disorders, congenital diseases)
- Patient with colour blindness
- Patient with multi-ligament injury or associated osteotomy
Show all 15Show fewer
- Patient enrolled in another study whose procedures may interfere with this study
- Protected patient: adults under guardianship, curatorship or other legal protection, or deprived of their liberty by judicial or administrative decision
- Subject with a BMI < 18.5 or > 30
- Subject who is professional athlete
- Subject with severe associated conditions (neurological, connective tissue disorders, congenital diseases)
- Subject with colour blindness
- Subject with multi-ligament deficiency or associated osteotomy
- Subject enrolled in another study whose procedures may interfere with this study
- Subject under legal protection: adults under guardianship, curatorship or other legal protection, or deprived of their liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Privé Jean Mermoz
Lyon, 69008
Bertrand SONNERY-COTTET, MD, + 33 4 37 53 00 22, sonnerycottet@aol.com
About this study
Anterior cruciate ligament (ACL) reconstruction is the major treatment option for ACL injuries. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after return to sport (RTS). The decision to RTS is therefore a critical one, as returning too early can increase the risk of recurrence, whilst a delayed return delays a return to pre-injury performance levels.
To guide this decision-making process, objective data is required to determine fitness for RTS. This is why the K-STARTS (Knee Safety Athletic Return to Sport) was developed. It is a composite test comprising functional and psychological assessments that enable the calculation of an overall score used to determine the functional recovery of the knee six months after ACL reconstruction.
Read more
Currently, functional tests are limited to measuring physical performance, whereas athletes often manage complex visuospatial processing whilst performing physically. It is therefore necessary to develop clinical tests that integrate neurocognitive and physical functions in order to better simulate the sporting challenges that lead to injury and thus improve preparation for RTS NEURO-K-STARTS is a battery of functional tests based on three standard horizontal jump tests from the K-STARTS, supplemented by four neurofunctional tests.
No evaluation of the NEURO-K-STARTS in patients undergoing primary ACL reconstruction has been published. This is why this research is set up.
Read the detailed description
Anterior cruciate ligament (ACL) injuries are debilitating for both professional and amateur athletes, with long-term implications for performance and return to sport (RTS).
ACL reconstruction is the primary treatment option. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after RTS. The decision to return to sport is therefore a critical one, as returning too early can increase the risk of recurrence, whilst a delayed return delays a return to pre-injury performance levels.
To guide this decision-making process, objective data is required to determine fitness for RTS. It is with this in mind that the K-STARTS (Knee Safety Athletic Return to Sport) was developed. It is a composite test comprising scored functional and psychological assessments that enable the calculation of an overall score used to determine the functional recovery of the knee six months after ACL reconstruction. It consists of 7 tests scored out of 100 points:
- A psychological test: the ACL-RSI.
- Six athletic tests: Single Leg Landing (landing on one leg: dynamic valgus), Single Hop Test (single jump), Triple Hop Test (triple jump), Side Hop Test (side jumps), Crossover Hop Test (crossover jumps), Modified Illinois Test
Currently, functional tests are limited to measuring physical performance, yet athletes often multitask, divide their attention and manage complex visuospatial processing whilst performing physically. It is therefore necessary to develop clinical tests that integrate neurocognitive and physical functions in order to better simulate the sporting challenges that lead to injury and thus improve preparation for a return to sport. NEURO-K-STARTS is a battery of functional tests based on three standard horizontal jump tests from the K-STARTS, supplemented by four neurofunctional tests.
The four individual neurofunctional tests that make up the NEURO-K-STARTS have been shown to be reliable in healthy subjects, but no evaluation of the NEURO-K-STARTS in patients undergoing primary ACL reconstruction has been published. This is why this research is set up.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Being tested
- NEURO-K-STARTS
- Keywords
- K-STARTS, NEURO-K-STARTS, ACL rupture
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEURO-K-STARTSBehavioural
NEURO-K-STARTS involves carrying out the three standard horizontal jump tests from the K-STARTS (Single Hop Test, Triple Hop Test and Crossover Hop Test), supplemented by four neurofunctional tests. It is the combination of these tests that makes up the NEURO-K-STARTS
| Study group | Role | What they receive |
|---|---|---|
| Healthy Arm | Active comparator | Healthy volunteers without ACL rupture Receives: Behavioral: NEURO-K-STARTS |
| ACL Arm | Experimental | Patients with ACL rupture Receives: Behavioral: NEURO-K-STARTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Influence Index
CII value is calculated for each neurofunctional test. This is the ratio of the performance achieved (Limb Symmetry Index; LSI) in the neuro version to that in the standard version of a given test.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659613
- Sponsor's protocol ID
- 2026-A00623-48
- Acronym
- NEURO-K-STARTS
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of NEURO-K-STARTS Following Primary Anterior Cruciate Ligament (ACL) Reconstruction
- ClinicalTrials.gov ID
- NCT07659613
- Acronym / sponsor ID
- NEURO-K-STARTS / 2026-A00623-48
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Keywords
- K-STARTS, NEURO-K-STARTS, ACL rupture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anterior cruciate ligament (ACL) reconstruction is the major treatment option for ACL injuries. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after return to sport (RTS). The decision to RTS is therefore a critical one, as returning too early can increase the risk of recurrence, whilst a delayed return delays a return to pre-injury performance levels.
To guide this decision-making process, objective data is required to determine fitness for RTS. This is why the K-STARTS (Knee Safety Athletic Return to Sport) was developed. It is a composite test comprising functional and psychological assessments that enable the calculation of an overall score used to determine the functional recovery of the knee six months after ACL reconstruction.
Currently, functional tests are limited to measuring physical performance, whereas athletes often manage complex visuospatial processing whilst performing physically. It is therefore necessary to develop clinical tests that integrate neurocognitive and physical functions in order to better simulate the sporting challenges that lead to injury and thus improve preparation for RTS NEURO-K-STARTS is a battery of functional tests based on three standard horizontal jump tests from the K-STARTS, supplemented by four neurofunctional tests.
No evaluation of the NEURO-K-STARTS in patients undergoing primary ACL reconstruction has been published. This is why this research is set up.
Detailed description
Anterior cruciate ligament (ACL) injuries are debilitating for both professional and amateur athletes, with long-term implications for performance and return to sport (RTS).
ACL reconstruction is the primary treatment option. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after RTS. The decision to return to sport is therefore a critical one, as returning too early can increase the risk of recurrence, whilst a delayed return delays a return to pre-injury performance levels.
To guide this decision-making process, objective data is required to determine fitness for RTS. It is with this in mind that the K-STARTS (Knee Safety Athletic Return to Sport) was developed. It is a composite test comprising scored functional and psychological assessments that enable the calculation of an overall score used to determine the functional recovery of the knee six months after ACL reconstruction. It consists of 7 tests scored out of 100 points:
- A psychological test: the ACL-RSI.
- Six athletic tests: Single Leg Landing (landing on one leg: dynamic valgus), Single Hop Test (single jump), Triple Hop Test (triple jump), Side Hop Test (side jumps), Crossover Hop Test (crossover jumps), Modified Illinois Test
Currently, functional tests are limited to measuring physical performance, yet athletes often multitask, divide their attention and manage complex visuospatial processing whilst performing physically. It is therefore necessary to develop clinical tests that integrate neurocognitive and physical functions in order to better simulate the sporting challenges that lead to injury and thus improve preparation for a return to sport. NEURO-K-STARTS is a battery of functional tests based on three standard horizontal jump tests from the K-STARTS, supplemented by four neurofunctional tests.
The four individual neurofunctional tests that make up the NEURO-K-STARTS have been shown to be reliable in healthy subjects, but no evaluation of the NEURO-K-STARTS in patients undergoing primary ACL reconstruction has been published. This is why this research is set up.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Arm | Active comparator | Behavioral: NEURO-K-STARTSHealthy volunteers without ACL rupture |
| ACL Arm | Experimental | Behavioral: NEURO-K-STARTSPatients with ACL rupture |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient who has undergone primary ACL reconstruction at least 6 months ago
- Patient who has undergone an isokinetic strength test, the results of which do not indicate any contraindications to performing a functional test
- Patient who has resumed performing horizontal jumps under the supervision of a healthcare professional
- Patient with no history of surgery on the joints of the contralateral leg
- Patient enrolled in or covered by a social security scheme
Key exclusion criteria (15 listed)
- Patient with a history of ligament surgery on the affected or contralateral knee
- Patient with a BMI < 18.5 or > 30
- Patient who is professional athlete
- Patient with severe associated conditions (neurological, connective tissue disorders, congenital diseases)
- Patient with colour blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEURO-K-STARTSNEURO-K-STARTS involves carrying out the three standard horizontal jump tests from the K-STARTS (Single Hop Test, Triple Hop Test and Crossover Hop Test), supplemented by four neurofunctional tests. It is the combination of these tests that makes up the NEURO-K-STARTS | Behavioural | ACL Arm, Healthy Arm |
Primary outcome
Cognitive Influence Index
Time frame: Day 0
CII value is calculated for each neurofunctional test. This is the ratio of the performance achieved (Limb Symmetry Index; LSI) in the neuro version to that in the standard version of a given test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEURO-K-STARTS in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand SONNERY-COTTET, MD (+ 33 4 37 53 00 22, sonnerycottet@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Influence Index (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.